Spurred by the general clamor in the European Union for obtaining the Russian vaccine, Spútnik V, experts from the European Medicines Agency (EMA) arrive this weekend in Moscow, where they will visit the Gamaleya National Center for Epidemiology and Microbiology of Moscow. In this institution the Russian drug was created and there all phases of clinical trials were carried out. The EMA’s task is to make an assessment that will allow the Spútnik V to be homologated for use in the EU as soon as possible.
And the fact is that the slowness with which the vaccination campaign is being carried out in Europe, when the doses arrive with droppers, now joins the stoppage that the AztraZeneca vaccine has suffered in several countries, Spain included. There is also the circumstance that this situation has led states such as Hungary, Slovakia, Czech Republic, Austria and now also Germany to go on their own. Italy and Greece have also been favorable to the Russian vaccine, as well as some Spanish autonomous communities.
So in this context, the EMA, which until now has been very reticent about the Spútnik V and has taken the task of authorizing it very calmly, is under heavy pressure. Only France agrees with the European regulator on the need to act with the utmost reserve.
But, given the possibility that the EMA will not approve the Russian antidote until June, the director of the Gamaleya Center, Alexánder Guíntsburg, has regretted that by then the European market will already be invaded by vaccines such as Pfizer, Jansen, Moderna and AstraZeneca. “In June the Spútnik V will no longer be so necessary,” Guíntsburg declared this week. At the Gamaleya Center, the idea prevails that the EMA is taking so long to authorize its medicine so as not to create competition for European vaccines.
The British scientific publication The Lancet described Spútnik V as “safe” and confirmed that its effectiveness is 91.6 percent, that declared by the Gamaleya Center. It is comparable, therefore, to Pfizer (95% effective) and Modern (94.1%), but superior to AstraZeneca (79%) and the rest of the available ones. The Russian drug to immunize against Covid-19 was the first to be registered in the world, in August last year. Currently, there are already 56 countries where its use has been authorized, including Argentina, Mexico, Bolivia, Paraguay, Venezuela, Algeria, Egypt, Iran, Morocco, Montenegro, Hungary and Slovakia.
However, the speed with which Spútnik V was developed, having been registered in Russia without having previously concluded all the phases of the trials, and the lack of transparency contributed to generate distrust towards the vaccine. However, Denís Logunov, deputy director of the Gamaleya Center, assured in July of last year that, when they decided to undertake the task of achieving immunization against Covid-19, against the SARS-CoV-2 virus, they had already acquired the experience of have prepared a vaccine against the Middle East respiratory syndrome virus (MERS), which spread during 2012 and 2013.
According to Logunov, “when the new coronavirus, the closest brother of the beta group viruses, appeared, we had no doubts about what to do and how (…) we limited ourselves to copying and pasting in the literal sense (…) It took us 14 days to get the vaccine. Despite his explanations, other factors play against him against the Russian medicine: the current geopolitical position of the Kremlin, immersed in a new confrontation with the West, the concentration of Russian troops along the border with Ukraine and the poisoning of the main adversary of Putin, Alexei Navalni.
50 million vaccinated
The Russian Fund for Direct Investments (RFPI), headed by Kirill Dmitriev, is the organization that has been in charge of financing the vaccine and now marketing it outside of Russia. Once the EMA approves the use of Sputnik V in the EU, says Dmitriev, “we will be able to supply the European Union with enough medicine to vaccinate 50 million people.”
If all goes according to plan, the director of the RFPI predicts a turnover of more than 20,400 million euros, an amount that would almost double that obtained by Russia in arms exports in 2020 (about 11,000 million euros), the newspaper reports. Niezavísimaya Gazeta, according to whose calculations, the price of each dose would be 8.5 euros. Much cheaper than, for example, Moderna, which is close to $ 20 per dose. The Spútnik V is currently produced in Belarus, Kazakhstan, India and South Korea, the latter two countries make it to send for the most part to Russia, so that it can vaccinate its own population.
According to Dmitriev, on January 19, they presented to the EMA a request for a “scientific consultation on the vaccine” and, on January 29, another request for the registration of the drug (…) such a procedure marked the beginning of the process of sending information to the EMA to undertake the continuous review «. However, the European body wrote on Twitter on February 10, assuring that it had not received “any request to carry out a continuous review or authorization to market the Spútnik V vaccine, despite information to the contrary”.
Later, on April 4, the EMA announced that the Russian vaccine was already in the “continuous evaluation” phase, which was the first step on the road to authorization and commercialization. Now in Russia they wait like May water for the specialists of the European regulator to give a definitive push to bring Spútnik V closer to EU users.
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